Medic Ice
FDA Label NDC 62001-0318

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Straight Arrow Products, Inc. for the product Medic Ice (NDC 62001-0318). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active IngredientMenthol 7%

Otc - Purpose

PurposePain relieving gel

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

UsesFor the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings



  • For external use only

Otc - Do Not Use

Do not use

  •  on wounds or damaged skin
  • with heating pads or heating devices
  •  with other ointments, creams, sprays or liniments
  •  with tight bandages

Otc - When Using

When using this product

  • avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if:

  • a rash appears
  • condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use.

Dosage & Administration


Directions

  • Adults and children 2 years and over: Clean skin of all other ointments, creams, sprays or liniments.  Apply directly to affected areas no more than 3 to 4 times daily.  Wash hands after application to help avoid contact with eyes and sensitive areas. May be used with wet or dry bandages or with ice packs.
  • Children under 2 years of age:  ask a doctor

Inactive Ingredient

Inactive Ingredients   Water, Alcohol, Laureth-4, Carbomer, Triethanolamine, Aloe Vera, Benzocaine, Thymol, Camphor, Methylsulfonylmethane (MSM), Glucosamine HCl, Chondroitin Sulfate, Oil Complex - (Oregano, Eucalyptus, Sage, Patchouli, Lavender, Rosemary, Ginger, Peppermint), Fragrance, Mineral Complex - (Magnesium Sulfate, Copper Sulfate, Calcium Sulfate, Calcium Carbonate, Lithium Chloride, Potassium Chloride, Sodium Sesquicarbonate, Ammonium Chloride), Herbal Complex - (Arnica, Slippery Elm, Chickweed, Comfrey, Myrrh, Hops, Marshmallow, Plantain, Green Tea), FD and C Blue No. 1.

Package Label.Principal Display Panel

ID:                        Med1Descriptive Text:   Medic Ice labelFile Name:            medicice.jpg

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